Offer summary
Qualifications:
Master's degree in Life Sciences or related field, Significant experience in regulatory strategies and filings, Mastery of drug and biologics regulations, Expertise in Quality Assurance/Compliance, Active Secret clearance and US Citizenship.
Key responsabilities:
- Provide regulatory oversight and advice to teams
- Develop and review regulatory documents for submission
- Create and maintain regulatory and quality documentation
- Conduct quality audits and oversee manufacturing activities
- Collaborate with internal and external professionals